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FDA Drug Application 018869 by BAYER PHARMS

Application Number018869
Application Type New Drug Application
Sponsor ApplicantBAYER PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/28/1988N       
AP04/24/1989SCS       
AP010/26/1989SCF       
AP012/7/1990SLR       
AP08/12/1991SLR       
AP04/16/1993SLR       
AP09/2/1994SCP       
AP010/24/1996SLR       
AP04/18/1997SCS       
AP012/15/1999SLR       
AP08/22/2000SE11531010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18869S10LTR.PDF 8/22/2000
AP08/22/2000SE11532010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18869SE10lbl.pdf 8/22/2000
AP08/21/2000SCM       
AP01/20/2006SLR13504014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018869s014lbl.pdf 1/27/2006
AP01/20/2006SLR13531014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018869s014ltr.pdf 1/30/2006




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